Lead Medical Writing Director — Clinical & Regulatory

Enigma Search; South San Francisco (CA); On-site; USD 130,000 - 160,000; Full time

Job summary

Enigma Search is looking for an Associate Director, Medical Writing in South San Francisco, California. This role involves leading the development of clinical and regulatory documentation, ensuring compliance with global standards, and managing the writing process. The ideal candidate will possess an advanced life sciences degree, with 8+ years in the field, strong communication skills, and the ability to collaborate effectively within teams. This position is vital for driving successful clinical program documentation and vendor coordination.

Qualifications

• 8+ years of medical or scientific writing experience.
• Deep familiarity with global regulatory requirements.
• Experience managing external vendors and/or contract writers.

Responsibilities

• Lead medical writer for clinical programs.
• Author and oversee development of regulatory documents.
• Contribute to medical writing processes and quality improvement.

Skills

Medical or scientific writing

Project leadership

Collaboration across teams

Attention to detail

Strong organizational skills

Excellent written and verbal communication

Education

Master’s degree in a life sciences field

PhD or PharmD preferred

Tools

Microsoft Office

Adobe Acrobat

SharePoint

Veeva RIM

Job description

Enigma Search is looking for an Associate Director, Medical Writing in South San Francisco, California. This role involves leading the development of clinical and regulatory documentation, ensuring compliance with global standards, and managing the writing process. The ideal candidate will possess an advanced life sciences degree, with 8+ years in the field, strong communication skills, and the ability to collaborate effectively within teams. This position is vital for driving successful clinical program documentation and vendor coordination.